Wound dressing devices and methods
The present invention provides an absorbent wound dressing assembly that can be used to stanch, seal, or stabilize a site of tissue injury, tissue trauma, or tissue access. The wound dressing assembly is flexible so that it can be adapted and used to fit in narrow and small wound sites. Generally the wound dressing assembly comprises a flexible carrier material that is impregnated with a non-mammalian material for control of severe bleeding. The preferred non-mammalian material is poly [β-(1→4)-2-amino-2-deoxy-D-glucopyranose] more commonly referred to as chitosan.
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The present application claims priority to U.S. provisional application, Ser. No. 61/049,831, filed on 2 May 2008.
BACKGROUND OF THE INVENTIONThe present invention is related to flexible wound dressings and more specifically to flexible wound dressings that have therapeutic qualities.
Controlling bleeding, fighting infection and improving wound healing are major medical issues. Methods to control bleeding and repairing wounds have existed for many years. Traditional surgical hemostatic techniques have included applying pressure, cauterizing, and suturing. Over the past 20 years, a number of hemostatic agents and tissue sealants have been developed and are currently used in various surgical disciplines. The hemostatic agents act to stop bleeding either mechanically or by augmenting the coagulation cascade, whereas tissue sealants are products that bind to and close defects in tissue. Currently there are five major classes of the hemostatic agents and tissue sealants for surgical use, including fibrin glue, bovine collagen and thrombin, cyanoacrylate, polyethylene glycol polymer, and albumin crosslinked with glutaraldehyde. These hemostatic agents are mainly composed of allogeneic or hetreallogeneic proteins.
Recently, chitosan based hemostatic dressings have been shown to control aggressive hemorrhages from severe external injuries. The chitosan dressing acts to control severe hemorrhagic bleeding by first sealing the wound site followed by promotion of local blood coagulation. An external form of this chitosan wound dressing was cleared by the Food and Drug Administration for external temporary control of severely bleeding wounds intended for emergency use.
However, in some applications, for example, a narrow entry wound, current chitosan and nonchitosan based wound dressing are not effective at providing hemostasis, fighting infection and/or promoting wound healing. Currently available dressings are often too stiff and too rigid to fit in a narrow space or they are too flexible and porous to efficiently promote hemostasis. Powder based hemostatic products also have limited effectiveness as they are difficult to apply to bleeding sites through narrow wound entries.
SUMMARY OF THE INVENTIONThe present invention provides a wound dressing assembly that can be used to stanch, seal, or stabilize bleeding at a site of tissue injury, tissue trauma, or tissue access. The wound dressing assembly is flexible so that it can be adapted and used to fit in narrow and small wound sites, while still providing sufficient stiffness at small wound sites so that it can properly address the wound site, promote hemostasis, and also capable of properly fitting to the wound.
Generally the wound dressing assembly comprises a flexible carrier material that is impregnated with a non-mammalian material for control of severe bleeding. The preferred non-mammalian material is poly [β-(1→4)-2-amino-2-deoxy-D-glucopyranose] more commonly referred to as chitosan. The combination of the chitosan on the carrier strip provides a unique structure, wherein the chitosan material forms films and layers extending between individual fibers interstices that comprise the carrier strip, with the films being dispersed in a varied arrangement throughout the dressing assembly.
An advanced supple wound dressing assembly for control of severe, life-threatening bleeding should preferably have the following properties:
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- i) easily and quickly applied in one step after removal from package;
- ii) rapid and strong blood clotting;
- iii) at least a minimal level of tissue adhesion;
- iv) strong internal cohesive properties;
- v) rapid and strong wound sealing;
- vi) resistant to dissolution under strong blood flow;
- vii) able to be treated roughly without compromising efficacy;
- viii) the dressing assembly must be flexible enough so that it can address narrow and oddly shaped wound sites, while having sufficient stiffness to allow for concentration of blood sells throughout the dressing assembly when being used.
Other features and advantages of the invention shall be apparent based upon the accompanying description, drawings, and claims.
Although the disclosure hereof is detailed and exact to enable those skilled in the art to practice the invention, the physical embodiments herein disclosed merely exemplify the invention which may be embodied in other specific structures. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.
The application is generally organized as follows:
A. Overview of the Wound Dressing Assembly and Its Uses
B. Manufacture of the Wound Dressing Assembly
C. Physical Description of the Wound Dressing Assembly
I. Preparation of A Chitosan Solution
II. Description of the Absorbable Carrier
III. Physical Characteristics
D. Results
E. Other Uses of the Wound Dressing Assembly
A. Overview of the Wound Dressing Assembly and Its Uses
A close-up representation of the arrangement of the supple wound dressing assembly 20 is demonstrated in
While prior art and conventional wisdom would indicate that the chitosan material 24 would be coated onto the carrier strip 22 and would outwardly fill in the area around and between the individual carrier strip fibers in the carrier strip 22, the present invention provides an unexpected arrangement. That is, there are voids retained in the assembly 20, as shown in
The unique arrangement will be evidenced more distinctly with respect to magnified views of the dressings. (scanning electron micrograph (SEM) images) (
The dressing assembly 20 is characterized by a unique combination of suppleness or multi-dimensional flexibility, with a permeability and absorbance capacity to blood flow, that enhance the hemostatic capacity of the hemostatic material 24 to stanch blood flow at a wound site. As
As shown in
The supple dressing assembly 20 provides a flexible structure 22 that can be adapted to a wide variety of wound shapes and areas, while the deposition of the hemostatic material 24 within the flexible structure 22 provides significant benefits in stanching and therapeutically treating a wound site 12.
The unique dressing assembly 20 can be characterized by a suppleness or multi-dimensional flexibility in terms of a Gurley stiffness value (in units of milligrams) (length×width) of not greater than about 10,000 (using a Gurley Stiffness Tester Model 4171D manufactured by Gurley Precision Instruments of Troy, N.Y., and Gurley ASTM D6125-97). It is believed that a dressing assembly 20 having a Gurley stiffness value (in units of milligrams) greater than about 10,000 does not possess the requisite suppleness or multi-dimensional flexibility to be flexed, bent, folded, twisted, and even rolled upon itself before and during use, and thereby comprising the integrity and/or mechanical and/or therapeutic characteristics of the hemostatic material 24 carried by assembly 20. However, the dressing assembly 20 should not have a Gurley stiffness value that is too low, as there will not be sufficient blood absorbance capacity within such an assembly. For example, a dressing assembly below a Gurley stiffness number below 200 is not preferable. The unique dressing assembly is characterized by a suppleness or multi-dimensional flexibility in terms of a Gurley stiffness value (in units of milligrams) between about 200-10,000, preferably between about 200-8000 and most desirably, between or about 500-6000.
The supple assembly 20 can also be characterized by a permeability to blood flow expressed in terms of a mean blood flow (in units of ml/sec). Blood flow is measured using the following procedure. A test piece of the dressing assembly that is 1″ wide by the necessary length to achieve 0.8 g is inserted into a 10 cc plastic syringe with a diameter of 1 cm containing 3 cc of citrated whole bovine blood. Manual pressure is applied to the sample for 2 minutes. The syringe is then attached to a tubing line with 60 mmHg pressure of citrated whole bovine blood. The syringe is inverted and the rate at which blood flows through the dressing is recorded. It is believed that a dressing assembly 20 having a permeability that is less than about 0.1 ml/s, preferably not less than 0.15 ml/s, possesses too much resistance to blood flow that will lead to blood finding paths of lesser resistance outside the confines of the assembly, thereby shunting blood flow away the hemostatic material 24 carried within the interstices of the assembly 20. Similarly, a permeability that is too high will limit the effectiveness of a hemostatic material on a dressing assembly, as it will not provide sufficient impedance for the blood as it passes through the assembly. The unique dressing assembly 20 is characterized by a permeability to blood flow (in units of ml/sec) between about 0.1-0.5 ml/s and most desirably, between about 0.15-0.35 ml/s.
The supple assembly 20 can also be characterized by an absorbance capacity for blood in terms of a mean absorbance (in units of g/g). Total blood absorbancy is measured according to the following procedure. A 2″×2″ test piece of the dressing assembly is pre-weighed (W1) and placed in citrated whole blood for 2 minutes. The sample is removed from the blood and the excess blood is allowed to drip off for 30 seconds. The sample wetted with blood is weighed (W). The total blood absorbance capacity is calculated as (W1−W)/W.
Optimal absorbance capacity will be maintained in the present dressing assemblies 20 while possessing the qualities discussed above. It is believed that a dressing assembly 20 having an absorbance capacity that is less than about 5 g/g does not possess the requisite ability to absorb blood into the interstices of the assembly into contact with the hemostatic material 24. Like the lack of requisite permeability, the lack of requisite absorbance capacity will lead to blood flow outside the confines of the assembly, thereby shunting blood flow away the hemostatic material 24 carried within the interstices of the assembly 20. The unique dressing assembly 20 is characterized by an absorbance capacity for blood (in units of g/g) of not less that about 5 g/g, and most desirably, between about 5-15 g/g.
The single drop absorption time, which is generally characterized as the time for a single sessile 20 μl drop of blood to decrease in volume to a 5 μl drop of blood, for the dressing assembly 20 is in a preferred range, as well. The time, expressed in seconds, is preferably between 20-300 seconds, and more preferably between 60-240 seconds.
The supple assembly 20 is characterized by the unique properties discussed above. The described assembly provides unique permeability, absorbance, and stiffness qualities, thereby providing an assembly that has effective and advantageous qualities of both stiffer and flexible prior art assemblies. The qualities of the dressing fall within a range not previously realized with hemostatic dressings, wherein the dressing has the adaptability characteristics of prior art gauze-style dressings, while providing hemostasis similar to pad-type products.
B. Manufacture of the Wound Dressing Assembly
A desirable methodology for making the wound dressing assembly 20 will now be described. It should be realized, of course, that other methodologies can be used. Generally speaking, the methodology consists of providing a solution of chitosan material 24, applying the solution to a carrier strip 22, removing excess solution from the carrier strip 22, and drying the carrier strip 22 to form the supple dressing assembly 20.
It should be understood that any process involving the addition of the chitosan solution 24 to the carrier strip 22 must be of a sufficient time so that the carrier strip 22 will thoroughly absorb the chitosan solution. In certain embodiments of the present invention, the chitosan solution 24 is effectively immediately absorbed into the carrier strip 22. It also should be noted that dry chitosan material could be applied directly to the carrier strip 22 after the carrier strip 22 has been wetted, i.e. after the carrier strip 22 absorbs the chitosan solution 24. As shown in
In
Referring further to the methods described in
After removal of the excess solution 24 and/or chitosan flake 26, the carrier strip 22 will be placed within an oven 80 to heat and dry the carrier strip 22 to form the wound dressing assembly 20, as shown in
Similarly, the drying temperature normally can be between 22°-100° C., more preferably between 40°-90° C. and more preferably between 50°-70° C.
After drying is complete, the wound dressing assembly 20 can be subsequently packaged in a pouch 28 as shown in
After pouching, the processed supple wound dressing assembly 20 is desirably subjected to a sterilization step. The wound dressing pad assembly 20 can be sterilized by a number of methods. For example, a preferred method is by irradiation, such as by gamma irradiation, which can further enhance the blood dissolution resistance, the tensile properties and the adhesion properties of the wound dressing. The irradiation can be conducted at a level of at least about 5 kGy, more preferably a least about 10 kGy, and most preferably at least about 25 kGy.
In an alternative step, an adhesive material 23 may be used to bind the carrier strip 22 with the chitosan material 24, which is shown in
The following two examples demonstrate general preparation methods for a wound dressing assembly according to the present invention. More detailed examples are described with respect to the table shown in
A cotton gauze (i.e. carrier strip 22) was soaked in 1% chitosan and 2% acetic acid solution (chitosan material 24) for 12 hours. The gauze was stirred dry in an oven at 50° C. for 24 hours. The dry gauze (i.e. the wound dressing assembly 20) was then rolled and packaged in a heat-sealable pouch. The package was sterilized using gamma irradiation. The wound dressing assembly 20 had a moisture content of 1.58±0.44%, with the residual volatile acid content ranging from between 1 to 3.5%.
Example 2A cotton-made gauze (i.e. carrier strip 22) was soaked in 1% chitosan and 2% acetic acid solution (chitosan material 24) for 12 hours. A chitosan powder (26) pretreated with acetic was coated on the gauze. The chitosan powder had a particle size of between 200 to 400 mesh and emitted zero or near zero volatile organic compounds. The excess powder was removed from the gauze, and the gauze was dried in an oven at 50° C. for approximately 24 hours. The dry gauze (i.e. the wound dressing assembly 20) was then rolled and packaged in a heat-sealable pouch. The package was sterilized using gamma irradiation.
The resultant wound dressing assembly 20 is capable of stanching the flow of blood and other bodily fluids at a wound site, as shown and described above with respect to
C. Physical Properties of the Wound Dressing Assembly
I. Biocompatible Material
The biocompatible material 24 of the wound dressing assembly 20 comprises a non-mammalian material, which is most preferably poly [β-(1→4)-2-amino-2-deoxy-D-glucopyranose, which is more commonly referred to as chitosan. The chitosan selected for the matrix preferably has a weight average molecular weight of at least about 100 kDa, and more preferably, of at least about 150 kDa. Most preferably, the chitosan has a weight average molecular weight of at least about 300 kDa.
The chitosan used to prepare the chitosan solution preferably has a fractional degree of deacetylation greater than 0.75 but less than 0.97. Most preferably the chitosan has a fractional degree of deacetylation greater than 0.85 but less than 0.95. Preferably the chitosan selected for processing into the matrix has a viscosity at 25° C. in a 2% (w/w) solution of 2% (w/w) acetic acid (AA) with spindle LVI at 30 rpm, which is about 100 centipoise to about 2000 centipoise. More preferably, the chitosan has viscosity at 25° C. in a 2% (w/w) solution of 2% (w/w) acetic acid (AA) with spindle LVI at 30 rpm, which is about 100 centipoise to about 1000 centipoise. Most preferably, the chitosan has viscosity at 25° C. in a 2% (w/w) solution of 2% (w/w) acetic acid (AA) with spindle LV1 at 30 rpm, which is about 100 centipoise to about 500 centipoise.
The chitosan solution is preferably prepared at 25° C. by addition of water to solid chitosan flake or powder and the solid dispersed in the liquid by agitation, stirring or shaking. On dispersion of the chitosan in the liquid, the acid component is added and mixed through the dispersion to cause dissolution of the chitosan solid. The rate of dissolution will depend on the temperature of the solution, the molecular weight of the chitosan and the level of agitation. Preferably the dissolution step is performed within a closed tank reactor with agitating blades or a closed rotating vessel. This ensures homogeneous dissolution of the chitosan and no opportunity for high viscosity residue to be trapped on the side of the vessel. Preferably the chitosan solution percentage (w/w) is greater than 0.5% chitosan and less than 4.0% chitosan. More preferably the chitosan solution percentage (w/w) is greater than 1% chitosan and less than 2.3% chitosan. Most preferably the chitosan solution percentage is greater than 1.0% chitosan and less than 2.0% chitosan. Preferably the acid used is acetic acid. Preferably the acetic acid is added to the solution to provide an acetic acid solution percentage (w/w) at more than 0.8% and less than 4.0%. More preferably the acetic acid is added to the solution to provide an acetic acid solution percentage (w/w) at more than 1.5% (w/w) and less than 2.5%.
An adhesive material may be added to the chitosan material, as well. The dressing assembly may be capable of forming an adhesive material in combination with blood flowing from said wound at a wound dressing-blood interface. Preferably, the adhesive material, when hydrated by interaction with the blood interface, preferably has a pH of not less than about 5.5 when the wound is sealed. More preferably, the adhesive material preferably has a pH of not more than about 6.5 when the wound is sealed. Most preferably, the adhesive material preferably has a pH of not more than about 7.5 when the wound is sealed. Preferably, the adhesive material comprises an acid selected from the group consisting of acetic acid, formic acid, lactic acid, ascorbic acid, hydrochloric acid, and citric acid.
The wound dressing of the present invention has at least a minimal degree of adhesion to the wound site. Prior art carrier strips generally display no degree of adhesion. Preferably, the degree of adhesion is between 1 and 40 kPa, and more preferably between about 10-40 kPa.
II. Description of the Absorbable Carrier Strip
The absorbable carrier strip 22 used in the present invention generally comprises a flexible material, such as a low-modular mesh, film, or weave, either of a synthetic or naturally occurring polymer. The strip 22 preferably is defined by interconnected strands, filaments, or strips of material. The strands, filaments, or strips can be interconnected in any one or a combination of manners including, but not limited to, being woven into a gauze, intertwined, integrally-formed, and the like. Preferably, the interconnection is such that the mesh can flex while substantially maintaining the dimensions of the openings defined thereby.
The material from which the absorbable carrier strip is fabricated may be a polymer (e.g., nylon, polyethylene, polypropylene, polyester, or the like), metal, fiberglass, or an organic substance (e.g., cotton, wool, silk, or the like). Commercial versions of acceptable blood absorbent strips are available as gauzes and bandages, such as Johnson & Johnson Nu Gauze All Purpose Dressings, Kling Rolls, and First Aid Gauze Pads, Kendall Kerlix and Kerlix Lite Gauze, and gauzes sold by such companies as Walgreens, Safeway and Rite Way, to name a few. Preferably, the carrier strip 22 may comprise a creped or butterfly material, with or without apertures.
The wound dressing has an available blood contacting surface area per base surface of said wound dressing of preferably at least about 100 cm2 per cm2, more preferably at least about 200 cm2 per gram per cm2, and most preferably at least about 300 cm2 per gram per cm2. The available mass of chitosan biomaterial per wound surface area is preferably at least about 0.02 g/cm2, more preferably at least about 0.04 g/cm2, and most preferably at least about 0.06 g/cm2
Furthermore, the wound dressing has a mean rate of dissolution per base surface area of said wound dressing when adhered to said wound site, at a temperature of about 37° C., of preferably not more than about 0.008 grams per minute per cm2, more preferably not more than about 0.005 grams per minute per cm2, and most preferably not more than about 0.002 grams per minute per cm2.
The wound dressing assembly 20 provides an improved flexible dressing that can be adapted for use on or at wound sites of varying sizes and degrees. The dressing assembly 20 is easily wrapped around an injured body part and also provides the necessary absorbency required for preventing blood and other bodily fluids from flowing outwardly from the wound site. This is accomplished while delivering a therapeutic agent to a wound site by way of the wound dressing assembly 20. The following discussion of the interaction of the carrier strip 22 and the chitosan material 24 will further demonstrate the advantages of the present dressing assembly.
An example of a suitable material is a combination of rayon and polyester in approximately 1:4 -3:4 ratio with an average density of 62.2±2.2 g/m2. mesh density with a special non-woven textile technique. The material was tested, and the results are listed below in Table 1.
III. Physical Properties of the Supple Dressing Assembly
Along with the carrier strip 22, the chitosan material 24 also defines an absorbable material. The combination of the absorbable carrier strip 22 and the absorbable chitosan material 24 provides the improved overall properties of the wound dressing assembly. Generally speaking, the chitosan material 24 will bind to the individual fibers that make up the carrier strip 22, thereby forming webs and films between the various individual fibers of the carrier strip 22. The dressing assembly 20 further has open areas for blood to seep into the assembly, as well as areas for blood cells to coagulate. That is, the arrangement has open voids that allow fluids to move upwardly into the wound dressing assembly 20, as opposed to moving outwardly around a bandage or gauze, as shown in the prior art in
The assembly 20 of the present invention (
It has been further determined that total blood absorbance capacity (TBAC) of dressing assemblies 20 of the present invention is in a range of 0.5 to 12 g/g (gram blood absorbed/gram gauze), preferable in a range of 2-8 g/g, with the range of material prior to the addition of a chitosan material being in a range of 8 to 16 g/g, preferable in a range of 10-14 g/g.
While the general arrangement of the dressing assembly has been demonstrated, other variables may have an effect on the overall efficacy of the material by providing different adhesion or stiffness properties, or by altering the contact angle of the gauze.
Comparisons were made between dressing assemblies that did not comprise any chitosan material (Uncoated) and dressing assemblies that contained chitosan materials (Coated), including different types of starting materials for the production of the chitosan (shrimp and squid). In addition, different materials were used for the carrier strip, as well (cotton and rayon polyester).
The wound dressing assemblies of the present invention were determined to have a degree of stiffness between about 30 and 2000 times of previously manufactured chitosan wound dressings, without a loss in the hemostatic properties of the assemblies. While both the dressing assemblies (cotton and rayon/polyester) containing a chitosan material had increased stiffness over the dressing assemblies that did not contain any chitosan material (i.e. Uncoated), the dressing assemblies that comprised a rayon/polyester carrier in combination with the chitosan material, as expected, showed higher stiffness compared to the Uncoated dressing assemblies.
D. Results
Example 3A wound dressing assembly as prepared according to Example 1, above was tested to determine its ability to control hemorrhaging. An auxillosubclavian injury was created in a porcine model. The injury was created with a 2-cm skin entry and was approximately 10-cm deep from the skin to the axillary artery. The axillary artery was trimmed to 3 cm length and dilated with vasodilator (1% lidocaine/paravine solution, having a 4:1 v/v ratio). A 4-mm diameter perforation injury was created in front of the axillary artery using a 4 mm vascular punch, from Ethicon, in N.J. The wound dressing was applied through the 2-cm entry to fill and pack in the wound under manual pressure for 3 minutes. After pressure was released the hemorrhaging from the wound was controlled.
Referring to
The various characteristics in
Similarly, the contact angle, blood absorbance capacity, and permeability for the dressing assemblies demonstrates improved structures for the present invention compared to the prior dressing assemblies. The contact angle (measured as the time that a sessile 20 μl decreases in volume to 5 μl drop) is 5× to 20× longer for the present invention compared to the prior art, 25-130 seconds and <5 seconds, respectively.
Table 2, below, shows the blood absorbance capacity (grams of blood/grams dressing) for the present invention compared to the prior art invention, after a 2 minute interval. Each of the assemblies 20 of the present invention is lower than that of the prior art, but provides sufficient absorbance capacity values.
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- p<0.05 for all present art compared to prior art
The permeability of blood (defined as the mean flow rate mL/sec of blood through the specimen) (see
The improved ability of the dressing assemblies of the present invention are further demonstrated by comparing scanning electron micrograph (SEM) images of the dressing assemblies. Images of the J & J Kling Roll (uncoated) dressing assembly are shown in
Conversely, the three assemblies of the present invention (100808, 120808, 08-XL-045) are capable of significant blood cell coagulation within the dressing assemblies. The three assemblies are shown in
The SEM images provide other possible dressing assemblies and compositions that could be formed according to the present invention.
Alternative additives or material may be added to the dressing assembly of the present invention. For example,
E. Other Uses of the Wound Dressing Assembly
The wound dressing assemblies of the present invention can also be incorporated for other uses. For example, the wound dressing assembly can be used to form an anti-microbial barrier; or to form an antiviral patch; or to intervene in a bleeding disorder; or to release a therapeutic agent; or to treat a mucosal surface; or to dress a staph or MRSA infection site; or in various dental surgical procedures, or combinations thereof.
For example the wound dressing assembly may further comprise an active ingredient. The active ingredient may include, but is not limited to, calcium, thrombin, factor VIIa, factor XIII, thromboxane A2, prostaglandin-2a, epidermal growth factor, platelet derived growth factor, Von Willebrand factor, tumor necrosis factor (TNF), TNF-alpha, transforming growth factor (TGF), TGF-alpha, TGF-beta, insulin like growth factor, fibrobast growth factor, keratinocyte growth factor, nerve growth factor, penicillin, ampicillin, methicillin, amoxycillin, clavamox, clavulanic acid, amoxicillin, aztreonam, imipenem, streptomycin, Kanamycin, Tobramycin, gentamicin, vancomycin, clindamycin, erythromycin, polymyxin, hacitracin, amphotericin, nystatin. rifampicin, tetracycline, doxycycline, chloramphenicol, vasoconstrictors, e.g. epinephrine and histamines, and combinations thereof.
The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While the preferred embodiment has been described, the details may be changed without departing from the invention, which is defined by the claims.
Claims
1. A wound dressing assembly comprising:
- a flexible carrier strip comprised of a plurality of individual fibers; and
- a chitosan material, said chitosan material forming a plurality of webs between said individual fibers of said carrier strip,
- wherein the assembly has a degree of adhesion to a wound site of at least about 1 kPa.
2. The wound dressing assembly according to claim 1 wherein said chitosan material comprises a chitosan solution containing between about 0.5%-4.0% (w/w) chitosan.
3. The wound dressing assembly according to claim 2, wherein said chitosan solution contains between about 1.0%-2.3% (w/w) chitosan.
4. The wound dressing assembly according to claim 1 wherein said dressing assembly further comprises an adhesive material.
5. The wound dressing assembly according to claim 4 wherein the adhesive material is lactic acid.
6. The wound dressing assembly according to claim 1, wherein said flexible carrier strip comprises a rayon material and a polyester material
7. The wound dressing assembly according to claim 6 wherein said flexible carrier comprises between about 25-75% rayon material and between about 75%-25% polyester material.
8. A wound dressing assembly comprising:
- a flexible carrier strip; and
- a hemostatic material, located on said carrier strip;
- wherein said dressing assembly has a stiffness between about 200 and 10,000 on a Gurley Stiffness test.
9. The wound dressing assembly according to claim 8 further having a stiffness of between about 500 and 8000 on a Gurley Stiffness Test.
10. The wound dressing assembly according to claim 9 further having a stiffness of between about 500 and 6000 on a Gurley Stiffness Test.
11. The wound dressing assembly according to claim 8, wherein the hemostatic material comprises a chitosan material.
12. A wound dressing assembly comprising:
- a flexible carrier strip; and
- a heomstatic material, located on said carrier strip;
- wherein said dressing assembly has a permeability between about 0.1-0.5 ml/s.
13. The wound dressing assembly according to claim 12, wherein the dressing assembly has a permeability between about 0.15-0.35 ml/s.
14. The wound dressing assembly according to claim 12, wherein said hemostatic material comprises a chitosan material.
15. A wound dressing assembly comprising:
- a flexible carrier strip; and
- a hemostatic material, located on said carrier strip;
- wherein said dressing assembly has a total blood absorbance capacity (TBAC) between about 0.5-12 g/g (grams blood absorbed/grams).
16. The wound dressing assembly according to claim 15, wherein the dressing assembly has a TBAC between about 2-8 g/g.
17. A wound dressing assembly comprising:
- a flexible carrier strip; and
- a hemostatic material, located on said carrier strip;
- wherein said dressing assembly has a single drop absorption time between about 20-240 seconds.
18. The wound dressing assembly according to claim 15, wherein said hemostatic material is a chitosan material.
19. The wound dressing assembly according to claim 18, wherein said flexible carrier comprises between about 25-75% rayon material and between about 75%-25% polyester material.
20. The wound dressing assembly according to claim 19, wherein the dressing assembly has a permeability between about 0.15-0.35 ml/s.
21. The wound dressing assembly according to claim 20, further having a stiffness of between about 500 and 5500 on a Gurley Stiffness Test.
Type: Application
Filed: May 1, 2009
Publication Date: Jul 8, 2010
Patent Grant number: 9205170
Applicant:
Inventors: Lisa Lucchesi (Portland, OR), Hua Xie (Portland, OR)
Application Number: 12/387,378
International Classification: A61K 31/722 (20060101); A61L 15/26 (20060101); A61P 17/02 (20060101);